Manager, Specialty Production

About the role

BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens, including human and animal tissues, cell products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research, aiming to improve patient outcomes by coupling comprehensive clinical data with donor samples. As the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes.

The Manager, Specialty Production serves as part of the ADME-Tox NC Site Leadership team responsible for providing supervision and technical direction for all specialty production, including product development and production, customer support, and ancillary scientific services. This role requires strong, hands-on scientific leadership, the ability to independently conduct laboratory experiments, critically analyze data, and determine next steps. Success in this role will be determined by the ability to develop and lead an entrepreneurial, scientifically oriented team through exemplary servant leadership.

This position may require up to 15% travel over the course of a year.

Responsibilities

• Oversee, manage, and maintain direct hands-on involvement in laboratory aspects and related specialty production, specifically blood and exosome products.
• Support development and utilization of automated product platforms and quality assessment tools in specialty production processes.
• Provide technical support for production.
• Establish and report on metrics that support Division and Company goals.
• Work directly with management to carry out business objectives and develop new research systems based on commercial need.
• Maintain effective communication, coordination, and working relations with other personnel and management.
• Keep management informed of area activities and significant concerns.
• Conceive of and develop new research areas, products, and contract services.
• Work with procurement partners and the business development team in presentations to pharmaceutical companies.
• Supervise employees in accordance with organizational policies and applicable laws, including training, planning, assigning, and directing work.
• Support managers and directors in performance appraisals, review weekly timesheets and time-off requests, and provide regular feedback.
• Set individual goals aligned with team and department goals.
• Ensure effective and efficient team production, adhering to company quality, production, and timeline standards.
• Reallocate resources and implement contingency plans when production targets and timelines are threatened.
• Responsible for schedule and resource planning to achieve team quality standards and production goals.
• Communicate job responsibilities and expectations to each employee.
• Monitor staff performance regarding progress toward career goals and communicate performance to employees, management, and human resources.
• Ensure laboratory staff complete all required safety training before conducting work and manage annual re-training as necessary.
• Ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, and general State and Country Regulations (e.g., CLIA, CAP, USP, ISO 9001, USDA regulations, HTA license, DEA, and State Controlled Substance programs).

Qualifications

• PhD in life sciences or related field with a minimum of five years’ experience in cell culture.
• MS in life sciences with a minimum of 10 years’ experience preferred.
• ISO, GMP, or GLP experience preferred.
• Working knowledge of biochemistry, chemistry, or cell culture.
• Proven ability to independently conceive, initiate, and develop research programs in line with business objectives.
• Exceptional organizational skills.
• Demonstrated published research.
• Proven track record of leading cross-functionally.
• Ability to analyze processes for compliance, determine, and communicate vulnerabilities.
• Demonstrated ability to adapt to changing priorities, manage time effectively, and set priorities for direct reports.

Physical Demands

• While performing the duties of this job, the employee may be required to: stand, walk, sit, stoop, kneel, crouch, crawl, speak, hear/listen, smell, and display manual dexterity.
• Specific vision abilities required include close vision, color vision, depth perception, and the ability to adjust focus.
• The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.

Work Environment

• Full-time position within a Monday-Friday work week during general business hours.
• Frequently required to use personal protective equipment to prevent exposure to hazardous materials.
• Potential exposure to fumes, airborne particles, toxic or caustic chemicals, biohazards, flammable liquids, and risk of radiation.
• Occasionally required to use equipment with moving mechanical parts, with risk of electrical shock and vibration.
• The noise level in the work environment is usually moderate; at times, hearing protection may be required.
• May work both inside and outside in heat/cold, wet/humid, and dry/arid conditions.